One trip — 6 days onsite in South Florida for summative testing
Hours
Flexibility to work 6:00 AM – 3:00 PM EST
Start Date
On or before September 1
Interviews
Beginning as early as next week
Position Summary
Our client — a global leader in medical devices — is adding a Human Factors Engineer to support usability engineering across an active product program. This is a hands-on role owning formative and summative evaluation work and the documentation that supports regulatory submission. The position is remote with a single onsite travel commitment for summative testing.
Key Responsibilities
Execute human factors and usability engineering activities in accordance with IEC 62366 across Class II and Class III medical devices.
Develop and maintain use-related risk analysis (uFMEA) to drive formative evaluation planning.
Plan, run, and analyze formative evaluations; support summative validation testing onsite.
Author and support human factors documentation and deliverables in support of 510(k) submission.
Partner with cross-functional engineering teams across both software and hardware elements of the system.
Communicate findings and design recommendations clearly to engineering, quality, and regulatory stakeholders.
Required Qualifications
Direct human factors experience with medical devices, Class II and Class III.
Working knowledge and applied use of IEC 62366.
Experience building uFMEAs, running formative evaluations, executing summative testing, and producing the required documentation.
Human factors experience supporting 510(k) submissions.
Experience across both software and hardware.
Strong written and verbal communication skills.
Availability for a 6-day onsite summative testing trip.
Preferred Qualifications
Advanced degree in Human Factors (MS or PhD).
Experience working within interdisciplinary teams (systems, chemical, software).
Background in robotics, surgical robotics, navigation systems, or spine.